Director, Global Regulatory Strategy

Regulatory Jobs; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a Director Regulatory Affairs—Global Regulatory Lead II to design and execute global regulatory strategies across multiple therapeutic areas, leading the Global Regulatory Product Team and coordinating with AST and cross-functional partners.

You will drive risk assessment, ensure compliance with worldwide regulations, and mentor GRPT members while guiding regulatory strategies through product development and lifecycle management.

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience.
• Experience in US & C region regulatory work and drug development.

Responsibilities

• Lead the GRPT to develop and implement global regulatory strategies.
• Interface with LRST/AST and cross-functional teams to align regulatory content with regulatory expectations.
• Proactively identify regulatory risks and mitigate issues.
• Oversee preparation of global regulatory product strategies across lifecycle stages.
• Provide coaching and mentoring for GRPT members and contribute to performance management.

Skills

Leadership

Global Regulatory Strategy

Cross-functional collaboration

Regulatory affairs

Project management

Stakeholder management

Communication skills

Education

Bachelor's degree in life sciences

Job description

AbbVie seeks a Director Regulatory Affairs—Global Regulatory Lead II to design and execute global regulatory strategies across multiple therapeutic areas, leading the Global Regulatory Product Team and coordinating with AST and cross-functional partners.

You will drive risk assessment, ensure compliance with worldwide regulations, and mentor GRPT members while guiding regulatory strategies through product development and lifecycle management.